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Medical Device Recalls
Class 2 Recall
Puritan Bennett KnightStar Ventilator

See Related Information
Date Recall
Initiated		 August 31, 2006
Date Posted January 09, 2007
Recall Number Z-0444-2007
Product Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLY-KS330-NA & DLY-KS330-SD
Code Information All units are subject to this notice (all serial numbers).
Recalling Firm/
Manufacturer		 Puritan Bennett Corporation
5931 Priestly Dr Ste 100
Carlsbad , California 92008-8813
For Addition Information Contact Michael P. Spears
925-463-4082
Reason For
Recall		 Directions for Use-Puritan Bennett has determined that a service interval should be defined for the device. The firm has also determined that an exhalation filter should be employed when the device is in use.
Action Domestic customers of record will be advised of this matter by letter sent via Certified US Mail, Return Receipt. The letter will provide recipients with simple instructions on how they may return their units for service, and provides scheduled dates for service for each of their devices, based upon Nellcor Puritan Bennett shipment records.
Quantity in Commerce 7,754 (in US)
Distribution Worldwide distribution ---- including USA and countries of Argentina, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Mexico, Netherlands, Norway, Poland, Portugal, Peru, Puerto Rico, Russia, Saudi Arabia, Scotland, Serbia & Montenegro, Singapore, Slovak Republic, South Africa, Spain, Switzerland, Syria, Turkey, United Arab Emirates, United Kingdom and Venezuela.
 

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